Unique Device Identification Webinar #11 - Accessing and providing feedback on the Australian UDI database 'Sandpit'
Presented by: Gary Pascoe, Therapeutic Goods Administration
Jasmin Hyatt, Therapeutic Goods Administration
Presented at: Online
Presentation date: Tuesday 19 July 2022
Presentation summary: Provide information to manufacturers, sponsors and users of the UDI data on how to access the AusUDID Sandpit.
Before we start I just wish to acknowledge the traditional custodians of the land in which we meet today, both here in Canberra and from wherever you're listening to the webinar from today.
I pay my respects to elders past and present and extend that respect to any Aboriginal and Torres Strait Islanders and their colleagues who are attending today.
Good morning. So, my name is Gary Pascoe. Some of you who have met me before or may have met me, I'm the UDI database Product Owner within the TGA and have been working on the development and the establishment of the UDI database for the last 18 months as part of the broader team.
I facilitate and run a number of sessions and did most of the presentation on the last webinar. So, it's a real pleasure to be with you again today and talking to you around where we're at with the Sandpit and what's happening with the UDI Sandpit.
As you can see from the slide there, I'll also be joined by Jasmin Hyatt. So, Jasmin also was introduced at the last webinar and Jasmin has recently joined us to run the UDI support team.
So, those of you who have been accessing Sandpit and have been granted access may have had the good fortune of dealing with Jasmin or members of her team.
Jasmin will be running the Engagement and Operations team and also going forward any questions and queries associated with the UDI and the database, will be fielded and managed by Jasmin.
Between the two of us we'll cover both of the sessions today and I just want to acknowledge both the work and the contribution of Jasmin.
I also wanted to pass on apologies from Michelle. Michelle van Wijk is sick today, so she just wanted to pass on apologies and apologise for not being able to join you.
She's had the unfortunate pleasure of catching one of the colds that's going around at the moment but thankfully she's testing negative to COVID. Michelle would certainly like to be here today and apologises for not being able to join.
As we've mentioned, today is very much around Sandpit. So, the focus of the conversation is around Sandpit. I will talk a bit about the progress and what we've done in relation to Sandpit and the process that we've taken to get to where we are.
Sandpit has been running now since the 4th of July, so effectively three weeks or coming up to three weeks.
And then also I wanted to talk to a couple of areas that we've received some questions and probably some challenges already, and so just provide some demonstration of how you can use the Sandpit to be able to register your account and create your account, but also then we've had some recent questions around the bulk upload of data.
Certainly, we'll walk you through how that works and how we are currently using it within Sandpit and then use that to go forward for any feedback that we receive on the bulk upload.
We also have a number of questions that have been asked in previous webinars and as other methods that have been in contact with the support team already. So, we've taken some time to put some of those questions into the slides.
We'll walk through those but also open the floor at the end of the session for you to ask your questions as we're going and raise any questions that we can answer in the time that we have permitting.
If we don't complete those questions that you raise, then we will be definitely sending the responses to those questions as part of the material that we're putting together for the webinar and also the support team will address those questions as we're going over the coming weeks.
So, with no further ado I just really wanted to present again around the AusUDID Sandpit.
The Sandpit, as I mentioned, was started in July and its purpose is very much around providing a tool for us to gather feedback, expose or to demonstrate some of the concepts that we're thinking around the AusUDID database, the Australian UDI records and rules. But also, then get some feedback and use it as a tool to work with the various stakeholder groups to receive your feedback on how we can make this database better suited to the way you operate and ensuring that we have a tool and have a database that best supports your business as we go forward.
Now, as I had mentioned in the past, any work that we do and any conversations we have around this will all be subject to final recommendations and endorsement from the Australian government.
So, there are things that we talk about, we cover as part of the UDI database and the work that we're doing within Sandpit, but obviously that will then be informed by your feedback, the feedback to the consultation paper. And will also then be finalised as part of the government regulations and the government recommendations around the establishment of the database and the regulations within Australia.
That process is still underway, and we have a number of questions that we've been asked leading up to today but also see as an advance copy of the questions that have been asked leading into this webinar around some questions about the implementation of the UDI database.
We're probably not in a position or we aren't in a position to answer a number of those questions, but we'll definitely look at them and push them out as part of the consultation process. But that will be subject to the Australian government.
So, we're very much looking at Sandpit as a tool to help us work through that process and that we're running at the same time that we have the consultation process running.
As we mentioned here, the aim of Sandpit was to cover, really to look at and meet the needs of four key user groups, so the sponsors and manufacturers, and we really aren't making any distinction within Sandpit in terms of the roles and responsibilities and what a sponsor and manufacturer can do.
We're essentially looking for them to create, update and delete UDI records via the portal and then also have machine-to-machine and NPC capabilities.
We're also looking to cover early adopters, so those organisations within the healthcare sector, in particular hospitals, registries, other healthcare providers, who are looking to use the UDI data to help the data and the database support their thinking about their implementation of UDI within the healthcare system.
And one of the things that we have constantly being reaffirming and considering is the use of that data will have a big bearing on how we supply it and how the database operates, but also the data that's being supplied.
The other key two user groups are the general public, so the ability to view and download data and provide a user with an excel file or a file that they can read and access the UDI data that may be in the database, as well as then support some of the TGA engagement and operations team around providing access and permissions.
So, as I mentioned at the start of this slide, the UDI database and the Sandpit version is very much a beta version that we're using to receive your feedback, test ideas, get concepts across and obviously we'll be running a number of sessions over the next coming months to be able to use that feedback and make refinements to the database as we go.
In terms of establishing the database, I know we've had some questions come in recently and a number of you may have seen this roadmap already. We've had quite extensive interest and quite a number of people expressing interest in joining the UDI Sandpit.
To ensure that we're in a position that we can have a phased and a managed implementation of the Sandpit, we didn't want to just open the doors from day one to all of those users, both in terms of ensuring that you had the right outcome and we would provide the right level of support to help you through that process, because aspects of the UDI database are still under development, so there will be questions that are coming up and understanding of how we've implemented.
So, to ensure that you've got timely and effective responses that we're able to service that need through the support team, but also ensuring that we weren't creating a whole bunch of issues around use of, and access to the database through high volume.
The plan presented on this roadmap here is really for a four month cycle and a managed implementation and introduction of users into the UDI Sandpit. So, for the month of July, for the first four weeks, we're looking to bring in two manufacturers and sponsors over the course of that four weeks.
So, our plan was to have eight manufacturers and sponsors introduced into the UDI Sandpit by the end of July.
We wouldn't be, but obviously because we have to establish the database and create a dataset that has the UDIs in it before anybody can use and view the data, obviously the intention was then to bring in and introduce data users and public users from August going forward.
Also during July, we were then looking to have some early testing and early considerations of a National Product Catalogue in the machine-to-machine transmission of data, and then having that bring greater use and take-up through August.
So, as you can see there, from then we're looking to have a progressive implementation over the coming months and having eight users from July or eight particular organisations from those manufacturers and sponsors representing and using the database, growing to 70 users in August, 110 in September and then 141 in coming months.
I know a number of you have registered and registered when we first started and have asked what's happening in terms of access. We certainly have received all your registrations and now we're working through progressively as part of the process to introduce and invite users into the database, so that we can ensure we can do that in a managed process.
However, having said that we are actually quite ahead, and I wanted to give you an update on what our status is with the Sandpit and the progress with the establishment of the Sandpit.
We are actually quite ahead of that number and we're really pleased to be able to tell you that we've had, since the Sandpit was open on the 4th of July and registrations opened on the 27th of June, we've had 145 registrations received.
Our registrations, that was as of Friday of last week, so close of business Friday last week, we've had 145 organisations expressing interest in joining and participating in the Sandpit.
Those registrations can allow for one or two users to be registered at the same time, so it actually is equating to about 165 users actually having access to the database.
Approximately 67%, just under 67% have nominated themselves as manufacturers and sponsors and are looking to use the database to create and manage and update UDI records.
So, that's very pleasing. I actually believe that number is higher because what we're finding is a number of manufacturers and sponsors are registering themselves as a public user with the intention of looking to create records.
So, Jasmin and her team are reaching out to you and asking what your intentions are, whether you wanted to be registered as a manufacturer because as the database, we manage the privileges and what functions you can perform within the database.
For example, a manufacturer and sponsor can create and amend UDI records. Obviously, we wouldn't like to see a member of the public create and amend UDI records, so there are different privileges and different functionality and responsibilities that go with that.
So, for those of you who are registered as a public user, we will be reaching out to you if it's apparent that you're a manufacturer and sponsor and asking if you want that other access.
So, a number of you have already said that at the time, that you would welcome the manufacturer and sponsor rights.
We have 38 sponsors and manufacturers representing 11 organisations. So, as you can see our intention was to have eight join by the end of July, if you remember from the previous slide. We're already ahead of that number with 11. That was as at Friday. I don't know, yesterday and today, as I speak I believe the team is actually creating and granting access to more.
So, we're now in a position where we're really comfortable. We feel that the initial access is working well, and more and more access will start to be granted over coming days.
We have had a number of questions and some issues around the access and creating accounts and logins, and particularly seeing when we first set up the database some issues around spam filters trapping emails.
And so, what I'll do is walk through that process of creating accounts and demonstrate that, but also if we have received or you have heard from the support team that your account has been created but you're not sure how to access it, please feel free to send an email to the UDI helpdesk. The contact details will be towards the end of these slides.
We have had some initial work around the machine-to-machine data connection, so using the Health HL7 SPL, so the Health Level 7 Structured Product Labelling, using the US FDA data format to receive that information, receive your UDI data electronically. And that will start to actually grow and we'll ramp up the access and the take-up of that in the coming weeks.
We'll be writing out to each of those who have registered interest in the machine-to-machine connection to ensure that you know what's required.
Because it requires a little more technical involvement and involvement of technical teams, we'll work with the individual manufacturers and sponsors and ensure that you can have that access and connection and we provide the information required.
Similarly, we're working with GS1 at the moment to finalise the connection with the National Product Catalogue, so there are some minor amendments and we're working with GS1 to determine what those amendments are so that we can ensure that the data being received from the NPC into the AusUDID database will flow into your UDI records.
And that has just been confirmed with a confirmation. We've tested and validated that and just in the last couple of weeks we've had our UDI Steering Committee approve the continuation of that connection.
So, we have probably a number of weeks of work with the GS1 to help finalise that, and then through GS1 we're coordinating that with those organisations and sponsors and manufacturers who are wishing to use the NPC to load UDI data into the database.
Again, we intend that to be a managed and a coordinated process rather than opening the floodgates to everybody and capturing tens and hundreds of thousands of records and creating a whole range of issues for you.
Because it is a beta environment, we are looking to ensure that we can manage that over the coming months.
In addition to the work that we're doing to bringing those organisations on, I'd like to thank those of you who have started to use the Sandpit version already and providing your feedback. We really welcome it and it's actually pleasing for us to receive the feedback through the various channels you have provided your information, as well as any issues.
We've had a number of issues that have been identified already. Probably the three major areas are around the login and clarity around the login process, and so I'll do a walk-through, a demonstration of that today.
Some issues around the creation of UDI records and data that's in the database, and we've released some minor fixes to correct those during the week. So, we've turned around a number of fixes and resolutions to those late last week.
And then the third area is around some feedback around the usability and just general look and feel of the Sandpit version. So far things are going well, but obviously we're looking to greater usage and greater feedback.
We only have a small number of records that are being created in the database, so we will be seeking your guidance and feedback to understand what issues you've encountered, whether there is something that you're looking for to be able to increase the number.
So, we currently about 11 records within the database that different manufacturers or sponsors have created, and obviously we're looking to grow that and get your feedback on how we can make that process easier for you.
We'll be releasing a survey to those in the next week to be able to then get your feedback on how we can improve the process.
As I mentioned, I really wanted to demonstrate two areas that we've probably received the most questions and feedback on to-date and walk you through the various processes and the steps that make that happen.
So, I'm just going to share my screen and flip over to another version of the TGA website, so hopefully you can see that.
So, what you have in front of you is... What I wanted to demonstrate in the first instance was the process for creating and registering your access. So, we've had a number of questions coming in.
Originally, we had a number of organisations, quite a large number of organisations register interest and we have sent out an email to those organisations who emailed us before the Sandpit was open, to ask for access to the UDI Sandpit.
For those organisations who are now coming on board, who are recently looking to use the Sandpit and may not have seen those initial introductory emails, I just wanted to walk you through another process, another means for getting access to the UDI Sandpit.
We have access through the UDI hub which is on the TGA website. What you can see in front of you is the TGA website. If I move my cursor over to the Industry menu bar, if you look down here, Medical Devices and IVDs, and then under there the sub-menu item is Unique Device Identification System.
So, I wanted to draw your attention to this page and just to highlight that there are two things here. The first one is, as you can see down here, we now have an element area on the page for registering for the UDI Sandpit which a user can click on, and I'll talk you through that in a moment.
But also, just to highlight that we'll be making a number of changes to the UDI hub to make more information and publish our FAQs and frequently asked questions around the sorts of information and the sorts of requests that people are making now.
So, the questions that you've sent today, the questions that we've received just prior to the webinar starting but also as part of the webinar, we'll be looking to start to publish out through the UDI hub which is this page on the TGA website.
You'll start to see some changes here and this is a little out-of-date and it is something that we are currently working through to get more information up to date so that it is more current in terms of the process, as well as give some feedback on where the UDI development process is at.
You'll see more information under News and Updates for example, and we'll use that more actively to publish that information.
However, the UDI Sandpit registration page is clicking on that link will take you to this page. So, those of you who haven't seen this before, this is a reasonably basic page for users to register their interest, and the process that we use for the UDI website is a four-step process for granting access to the Sandpit.
The first step in the process is, as I mentioned here, access through the TGA website and the UDI hub or a direct link if you have it, which is really then completion of that registration page.
To help us manage the process and to manage the access and the take-up of the Sandpit, that information then is fed to our UDI support team, which is led by Jasmin. And then we will be progressively granting access and providing access to different user groups or different organisations over the next week or two.
So, if you have already registered your access or registered your interest, Jasmin and her team would have received that information and are currently working through in terms of our rollout cycle of the take-up and the introduction of the different sponsors and manufacturers.
And then in August we'll look to grant access to public users and other organisations looking to use the UDI data. As they view and approve that process then an email will be sent, and I'll show an illustration of that email, and then you'll be invited to create your online account.
This is all being built on an online self-service paradigm and concept of once you have that email with the link in there, you can create your online account and that will then give you the ability to set your password and then grant you access to the UDI Sandpit through an online version.
At the same time, it also will allow those users nominated and any users to have access to the machine-to-machine access method, and as I mentioned we'll be working through that with a number of key stakeholders in the coming days around getting access to that machine-to-machine and providing all the technical details to require that to happen.
So, as you can see, there's a registration page. As you register, you'll click on the registration link, and we'll prompt you for a number of questions and ask you some details.
This information is useful for the TGA to help understand the profile. It's not really relevant to access within the UDI database, but it is helping us understand what the needs are from the different organisations or different users looking to access the Sandpit.
So, as you can see, we'll walk through that process and once you complete that information, we'll ask you to complete or to select what basis you'll be using the Sandpit.
Depending on your response, we will actually provide you different access. And as I mentioned before, I myself want to register as a manufacturer. As I click through that, then you'll be prompted with other information.
I won't go too much further into this process, but those of you who haven't accessed the Sandpit or haven't been able to register, I strongly encourage you to access the TGA website and the UDI hub, which is in a link provided in this presentation, but also I believe there's a link that's provided in the chat for this webinar as well.
I'll close that page. Once you have been granted access you will see an email that will look like this.
So, Jasmin and the team will review the applications and then you will receive an email that will be sent to you from the TGA AusUDID mailbox, and it will say we're pleased to advise you your registration has been approved. To create your account, please click here.
Clicking on the link will take you into the ability to create a UDI account. So, this is where we're effectively asking each user to then create their own account, add their own password.
For those users you will see this screen and we did have some minor changes to update the use of this screen. So, those of you who haven't been granted an access to the UDI Sandpit, then click on this Create Account, and if you have been granted access, then essentially sign in with your email address.
So, I will be signing in as part of my… then essentially the user will be presented with this sign in screen.
Manufacturers and sponsors, as you will see, will be presented with the ability to land on their Sponsor/Manufacturer Centre page. If you're a general public user, then you'll be presented with different information.
So, what I'd like to do now is actually demonstrate the bulk uploads. So, bulk uploads are an area that we have in place already. We've received a number of questions from sponsors and manufacturers about how we use the bulk uploads.
It is an area that at this stage has been a simple implementation of the ability to upload UDI data into the database if somebody doesn't want to use the machine-to-machine capabilities, NPC, which isn't ready yet.
So, if you're looking to upload a number of UDI records one by one, then we're looking at encouraging the use of the online portal. If you're looking to create records in more volume and greater volumes of records, then we have created the bulk upload capability.
I just wanted to walk you through and provide some demonstration of that capability now.
So, what I've taken you to now is essentially before it was a login and access, so as a sponsor and manufacturer, this is actually within our demonstration site, so it isn't within the Sandpit version.
As you will see, I have a number of options and a menu bar at the top of the page which is effectively providing a number of features that any user will receive. And then as a sponsor and manufacturer I have a menu bar which is then providing different functions and different services that I can use as a manufacturer or a sponsor.
You can see here I can click on My UDI Records and we'll demonstrate the UDI records that have been created for me as a manufacturer and sponsor. I have the ability to add a UDI record and create the data and use the online portal to be able to create a single record as well as then having the ability to bulk edit UDIs.
I'm looking to demonstrate this ability to bulk upload UDI records at this point in time.
So, the first step in bulk uploading UDI records is obviously what is the format and the template for an excel file? So, the way we have developed the application is that you will have an excel file, you put your UDI information into an excel file, then you upload that into the database.
And obviously the format and the content of that excel file will be important to where that is loaded into the database.
So, we've built this capability to say you can download a template to get started. So, if I click on that download button, essentially you see on the right-hand side there, it will download a bulk UDI file called Bulk UDI Upload Template dot Excel, into my Downloads folder.
So, that template, if I click on that it will then provide me with a sample template, an excel template that will prompt me for the different data for the bulk upload.
So, one of the things I wanted to stress or point out to everybody is the process that we have at the moment as we talk about here, to use this tool, to use the bulk upload tool, the way we've currently designed the application and the Sandpit version is to upload records in bulk as one file per UDI record.
So, what that's saying is one excel file, so if you're creating one UDI record then it is one excel file. If you are looking to create ten UDI records, then we will be looking for you to create ten excel files, which you will then progressively load into the database.
So, we've had some questions asked around, how do I link the UDI Device Identifier to other attributes in the spreadsheet?
We've managed that relationship between the UDI and all the other dependent information around the device identifier such as other DIs, other codes, storage and handling, clinical characteristics, by managing having one file per UDI record.
Now, we're already had some early feedback about the usability of that and we would welcome you to have a go and try that process and provide your feedback in terms of support or otherwise in terms of this process.
As we say, we have one UDI file per record, and so what we have done within this file is a template then to be able to prompt the user and show the user with their particular attributes that they need to supply.
So, the excel file as you will see, the first row has some information at the top of the row. And then some of those fields are highlighted in red. That red indicates that they are mandatory fields, so that is information that is expected and needs to be supplied as part of the bulk upload.
Anything that's not been highlighted in red is then optional data. As you scroll from left to right, you can go across the file and you see other attributes which matches the data model, the current data dictionary for the AusUDID which is in draft.
But those of you who have been working with the technical working group, you will see a number of fields that we have had feedback that were in the data dictionary that are currently in our draft data dictionary, and we've had feedback from our technical working group that these are not required.
For the moment we have kept them in to the bulk upload, but obviously no value in there, will not be loaded into the UDI database. And we'll finalise that structure once we have the completion of the technical working groups and the regulatory consultation.
So, as you scroll through, as you can see, there are a number of fields and attributes associated with the version numbers, any URLs, additional information, and then other attributes about the device.
So, we've looked to make that as straightforward and simple, looking to get your feedback on how we can improve this bulk upload process and the attributes that we're providing through the bulk upload as part of our Sandpit review.
The blue text on row two is essentially illustrative and is a sample text that you would put in. So, in here you would end up entering the primary identifier, so the UDI-DI that may apply to this record, the issuing agency and then other attributes of the device as we scroll through.
Everywhere the blue text on row two should be overtyped or is to be typed over, so the information in there is for example only to help the user understand what values they need to put in.
So, for example if I look at the MRI safety status, what we've done is we've created different example text that actually shows the different values that could be entered into that field.
So, for example, labelling does not contain MRI safety information, MRI conditional, MRI safe, MRI unsafe. So, the user will then go through and select and delete out some of that information and then create a record based on that sample text.
As I mentioned before, if you create another record in row three, then the upload won't read that information. So, it will only ever be reading one record from row two in that table.
At the bottom of the spreadsheet, in the excel spreadsheet template, you'll see a number of tabs and we're using that to collect the other attributes associated with the device, such as secondary identifiers.
So, we would then provide any additional identifiers. It may be an alternative or any secondary identifiers that may be used for this particular UDI. Previous identifiers, so if this UDI was superseded or replaced by another and you wish to supply the UDI-DI for prior identifiers then please provide that information in here.
We capture package information and then package information will provide the different attributes of the package, so the package UDI-DI, the quantities, the type of packaging and then the identified and discontinued date.
The second last tab is looking at the clinical sizes and providing information around the clinical size. As you see here, we present a range of values that will be acceptable as part of that process. All these values match what's actually in the database in terms of values to be provided, and storage and handling.
So, I'm going to close that and just bring up an example. What I've done is I've created a number of sample records. I'll just bring the first one up, just to illustrate to you what the device identifier is and what would be the attributes in the bulk upload.
So, there's an example of a record that has been created. I've put in here, UDI-DI, so these are some test records that I've taken and started to create to simulate the bulk upload.
I've put this information in and as you can see, I've shown some examples... I can edit this data and actually have the database pull that information up.
So, what I've done is I've created three versions of a device and three variations, so a small, medium and large variant of that device, for mesh, a 2.5 centimetre, four centimetre and an eight centimetre device.
I've got examples, so as you can see here, because I've created three devices I have three records, so one, two and three. Now, the process that we'll have is you can create and upload that information by one of two means.
You can drag and drop. As you see here, I've highlighted those three records. I can drag and drop them into the database on the screen page. I can drag and drop them into the page here and just copy them in and that will process the file.
Or alternatively, I can click on this box in here and I can select all those records I want to upload.
So, I'm uploading the three records that I've processed. As you can see, what it will do is once I've dragged and dropped or added those files to the bulk upload screen, it will do an element of validation of the data that's already there. And it will check from a number of different things to ensure that the format of the data in the spreadsheet is correct and present those errors underneath the file name or ranging right through to then say, is this for a device that is already in use?
So, I've deliberately created a record that is consistent with a UDI-DI that already exists in the database, and some others then that I actually wanted to use to highlight some challenges that we have.
So, you will see this information being presented and essentially that will give you some guidance on the correctness and the validation of your bulk upload file.
I'll just delete that text. I'll make a minor change to one of the records. And I really wanted to highlight, as you're working through this, one of the traps and tips in terms of where people have been getting caught.
Because it’s an Excel file, a UDI-DI will generally have, a lot of them have leading zeros. Because it’s an Excel file, what happens is the Excel will actually truncate or take the leading zeros off the UDI-DI. The consequence is that it will actually take the data and read it. So, what I’ve done is, if I just type the number in, it will truncate the leading zeros off the front. One of the things that we encourage, we remind you to if you use the apostrophe, put in the two leading zeros to give us a 14-character for the UDI-DI and in this case it’s a GS1 GTIN and put that information into the database.
Secondly, then we have to ensure that all of the data that’s related to all the sample data that may exist in the template, is deleted. So, this is one of the records that I mistakenly kept in, to the database from the sample template and it gave me an error. Because it is saying this package identifier was not valid GS1 GTIN.
So, if I delete that information and go back to saving that file, and now if I take that file and drop it into here, you will see it’s been successful. So, the message we had before was to say that the package ID was not correct. Once I’ve done that validation, it’s successful, I can upload the UDI record and essentially reset and upload more.
Once I can look at that record as being sent, it actually creates a version in my Draft records. And so, as a user of the application, it won’t create a new UDI record in my current records, it’ll actually create a version in our…
In the interest of time, I think I might just cut it short there. As I say, there are a couple of traps that we need to, as you’re using the bulk UDI, to ensure that you enter the leading zeros and use the Excel spreadsheet in a way that caters for those leading zeros.
I’m actually going to stop sharing. I know there’s a number of questions coming through so rather than walking through those examples even more, we might actually lead to some of the questions.
I think there are a couple of questions around, we’ve had some early feedback, the first one is on the bulk upload. Asking for different ways of dealing with the bulk upload and using one Excel spreadsheet for multiple files, and others providing a view on whether we use one Excel spreadsheet. So, we would like to ask that you try the bulk upload and provide your feedback to us through the feedback streams on the pages in the application, or alternatively send the information to the UDI helpdesk.
So, what I might do Jasmin, you’re probably happy to not hear me talk anymore, so handover to Jasmin, and actually talk through some of the questions and answers that we may have received.
While Jasmin is doing that, I may look over some of the questions that we received. Thanks Jasmin.
Okay, so I think some of these questions and answers might answer some of the questions we’ve got coming up in the live chat.
The reason we’ve designed them like this, is to answer as well, is just for those of you who may have colleagues that might have missed today’s session, and who might actually want to download a PDF copy of these slides when they are available on the website in the coming weeks.
First question, how and when can I access the Sandpit? So, I see a lot of questions coming in about people who have registered and haven’t yet been granted access. So, the process is, you will register which as Gary showed us earlier, is through the UDI Hub. And then it’s up to our team then to actually grant you access. As Gary discussed earlier, we are doing that in phases for numerous reasons, but one of the big reasons is just to control the quality and make sure that any questions that the users have as they are rolled out, that we are able to answer those as fully as we can.
So, you may have registered, and thank you for your patience for those of you who have registered and are just really eager to use the Sandpit, we just may not have granted you access yet.
When we do grant you access, you will receive an email prompting you to go and complete your account creation. I know that there have been some issues. Some people have for instance, you may have really high security on your firewall settings, or it may just be in your junk email. If we have contacted you and let you know that we’ve granted you access and you haven’t seen that email yet, just check your junk folder first.
But you can always contact us, that’s what we are here for, so if you are unsure either way. If you think you have registered and maybe have been granted access and don’t have access to the email yet, just give us a call or send us an email. The details are at the bottom of this slide here on one of the questions, but also through our app as well. So udi at health dot gov dot au, or you can give us a call.
The next question, when will the Sandpit be open and for how long? Well, Sandpit is already open and as I said, we are rolling out access and the Sandpit will actually be available throughout this process and when we go into production early next year.
So, when we go live with UDI next year, the Sandpit will still be a function that’s available. It will change with its look and feel, and we’ll be using that as more of our test site for people to try to upload data before they have to do that in the live UDI production environment.
Some other questions there, does Sandpit link to your TBS account? So, if you have a TBS business services account, most sponsors will, it doesn’t link to your TBS account, unfortunately. There are a number of changes going on across TGA and the Department with updating logons and how we interact with all of our stakeholders, not just our sponsors and manufacturers. But at this stage, no, the Sandpit does not link with your TBS account, so it is a separate login that you create, again, through the process that Gary and I have discussed.
Basically, you can contact us, our details are there. So, will there be a template? Gary has just stepped us through. When you’re uploading data, if you are using that Excel format to upload your data, then yes, there is that template there that Gary has showed us.
Proposed timelines are also there. I think we’ve shown this in some previous webinars. These are proposed timelines only at this stage, but you can see there, Sandpit is currently available, and we’re looking for voluntary compliance from January 2023. So, again, we plan to go live with the production environment of the AusUDID from January next year.
Again, we are waiting on getting through the changes to the regulations, and I know there was a question in there about the consultation paper as well, so I will jump around a bit just to try and answer people’s questions. But it ties in with this timeline as well, so consultation paper we are hoping to launch for feedback either this month or next. We’re just waiting on some final things before we get the go ahead to do that. So, please look out on the TGA website, on the UDI Hub, we will have more information there when the consultation paper does go live, in the next few weeks hopefully.
Finally on this slide, is the data used in Sandpit live data? So, I can see there are questions coming up as well in our chat today on this. The data may be live, it may be real device data that sponsors and manufacturers choose to upload. If you are a sponsor or a manufacturer, you may want to upload some dummy data or some test data. Either way, we are treating all data that is uploaded in Sandpit as test data, which means it’s not to be used in a real clinical environment. So, we are just putting that caveat in there, that that data is not to be used for medical purposes.
Now, I am aware we’re at 12.31 so I want to thank everyone for your patience. Gary, we might just stop there. But again, if anyone has any questions, if you feel you have some more questions now, please feel free to email us, udi at health dot gov dot au. And our details are also available on the UDI Hub as well for those of you who may have missed today’s session.
We will be answering the questions that have gone unanswered in the next UDI webinar, and again, if you have anything you’d like to know, any topics that you’d like us to cover for future webinars, please email your suggestions to us at udi at health dot gov dot au.
Thank you, guys.
Thanks Jasmin. I’m scrolling through a lot of the questions and I feel there’s a number of them we can answer through the Hub, so we’ll put that information out and distribute it to everyone that is registered here as well as our workings groups.
Some of you have said you’ve already registered for Sandpit, late June early July, and haven’t been granted access. A couple of you who asked are anonymous, so please just email to the UDI mailbox that’s on the screen here and we’ll endeavour to get you access in the next couple of days.
So, thank you again everybody, thank you Jasmin, and enjoy the rest of your day.
- Committee meetingsAdvisory Committee on Complementary Medicines (ACCM) meeting
- Committee meetingsAdvisory Committee on Biologicals (ACB) meeting
- Committee meetingsAdvisory Committee on Medicines (ACM) meeting